Different Modes of Isotonic Exercises for Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis
Status
Recruiting
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Standard physical Therapy
Closed Kinetic Chain
Open Kinetic Chain
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee, Osteoarthritis, Kinetic exercises, Biomarkers
Eligibility Criteria
Inclusion Criteria:
- ≥40 years of age;
- having knee pain;
- having at least three of the following additional symptoms: a-morning stiffness ≤ 30 minutes, b-crepitation, c-bone margin tenderness, d-bony enlargement or e-no palpable warmth;
- willing to provide informed consent
Exclusion Criteria:
- Knee joints showing Kellgren and Lawrence (K-L) grades 1 or 4;
- rheumatoid arthritis;
- serious pathological conditions (inflammatory arthritis and malignancy); total or partial arthroplasty of the affected knee joint, or on a waiting list for joint replacement surgery;
- recent surgical procedure of the lower extremities in the previous 6 months;
- uncontrolled hypertension and unstable cardiovascular problems that could subject the participant to increased risk with exercise and physical exertion;
- physical incapability to safely perform exercises, walking or stationary cycling, as in debilitating visual defects, neurological problems, exaggerated low back pain, advanced osteoporosis, and inability to walk 10 meters without an assistive device;
- use of prescribed analgesics, corticosteroid or analgesic injection intervention for knee pain within the previous 30 days;
- lack of clear comprehension of study procedures or inability to comply with instructions;
- stated inability to attend or complete the proposed course of intervention and follow-up schedule.
Sites / Locations
- King Fahd Military Medical ComplexRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Standard Physical Therapy
Open Kinetic Chain
Closed Kinetic Chain
Arm Description
Control group for the study.
Standard care in addition to open kinetic chain exercises for the knee joint muscles.
Standard care in addition to closed kinetic chain exercises for the knee joint muscles.
Outcomes
Primary Outcome Measures
Change in pain score using the Arabic version of the Western Ontario and McMaster Universities (WOMAC) index
A 5-point Likert scale comprised of 24 questions across 3 subscales. Standardized answers are assigned a score from 0 (no symptoms) to 4 (extreme symptoms) with higher scores indicating worst pain, stiffness, and function.
Change in function score using the Arabic version of the Western Ontario and McMaster Universities (WOMAC) index
A 5-point Likert scale comprised of 24 questions across 3 subscales. Standardized answers are assigned a score from 0 (no symptoms) to 4 (extreme symptoms) with higher scores indicating worst pain, stiffness, and function.
Secondary Outcome Measures
Change in knee pain using the Arabic version of the Numeric Pain Rating Scale (ANPRS)
A horizontal 11-point scale (0-10), with 0 indicating no pain and 10 indicating the worst pain ever.
Change in isometric muscle strength
Measured in Newtons for the Quadriceps and Hamstring muscles using a hand-held dynamometer (Commander Muscle testing, JTech, USA). The greater the recorded value the better the muscle strength.
Change in knee joint range of motion (ROM)
Active knee joint flexion/extension ROM measured in degrees using an electric goniometer (Biometrics Ltd, DLK900, UK). The greater the recorded value the greater the knee joint ROM.
Change in knee joint proprioception
Active repositioning error of a given passive position of the knee joint will be assessed using an electric goniometer (Biometrics Ltd, DLK900, UK). The lesser the recorded value the better the knee joint proprioception.
Change in knee OA biomarkers
Serum (10 ml blood) and urine samples will be collected from the participants and analyzed using the Enzyme-linked immunosorbent assay (ELISA) technique.
Full Information
NCT ID
NCT04909086
First Posted
May 26, 2021
Last Updated
September 29, 2022
Sponsor
Prince Sultan Military College of Health Sciences
Collaborators
King Fahd Military Medical Complex
1. Study Identification
Unique Protocol Identification Number
NCT04909086
Brief Title
Different Modes of Isotonic Exercises for Knee Osteoarthritis
Official Title
Effect of Different Modes of Isotonic Exercises on Clinical Outcomes and Cartilage Biomarkers in Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 21, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prince Sultan Military College of Health Sciences
Collaborators
King Fahd Military Medical Complex
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a randomized controlled trial examining and compare the effects of open and closed kinetic chain exercises on pain, function, and cartilage synthesis and degradation biomarkers after an eight-week rehabilitation program for knee osteoarthritis (OA) patients.
Detailed Description
Design and Subjects: A prospective, active control, three-parallel-group, assessor-blinded, randomized controlled trial. A sample of 120 subjects will be recruited and randomly assigned to one of three study groups at a 1:1:1 allocation ratio (40 participants per group): a) Standard care only, b) Closed kinetic chain exercises plus standard care, and c) Open kinetic chain plus standard care.
Intervention: participants will receive 24 treatment sessions (3 sessions/week) over 8 weeks. Participants will be allocated to the experimental groups will receive the standard care protocol in addition to either closed or open-chain exercises.
Outcome measures: The primary outcomes are physical function and pain assessed using the Western Ontario and McMaster Universities (WOMAC) scores. Secondary outcomes include the Numeric Pain Rating Scale, quadriceps and hamstring strength, joint range of motion (ROM), joint proprioception error, and serum and urine OA biomarkers including the Serum cartilage oligomeric matrix protein (COMP), Serum propeptide Type-II N-terminal (PIIANP), Serum C- reactive protein (CRP), and Urine type -II Collagen telopeptide (CTX-II).
Data Analysis: Data will be analyzed using the intension-to-treat (ITT) analysis with multiple imputations. The primary analysis of the primary outcomes at a two-month follow-up time point (after completing the intervention protocol for 8 weeks) will be carried out using a mixed-model analysis of variance (ANOVA) test with adjustment for a set of pre-specified baseline factors. Secondary analysis using the ANOVA test for the primary outcomes at a six-month follow-up time point, and secondary outcomes at all follow-up time points will also be carried out.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Knee, Osteoarthritis, Kinetic exercises, Biomarkers
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Both the outcome assessors and the study statistician will be blinded to group allocation.
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard Physical Therapy
Arm Type
Active Comparator
Arm Description
Control group for the study.
Arm Title
Open Kinetic Chain
Arm Type
Experimental
Arm Description
Standard care in addition to open kinetic chain exercises for the knee joint muscles.
Arm Title
Closed Kinetic Chain
Arm Type
Experimental
Arm Description
Standard care in addition to closed kinetic chain exercises for the knee joint muscles.
Intervention Type
Procedure
Intervention Name(s)
Standard physical Therapy
Intervention Description
Patients assigned to this group will receive a 40-min multimodal supervised physical therapy treatment comprised of warm-up (10-min cycling/walking), muscle stretching, neuromuscular control exercises, and ten-minute transcutaneous electrical nerve stimulation (TENS). Manual mobilization techniques may be applied as necessary according to the findings of the physical examination. Treating physical therapists will prescribe exercises based on a predetermined list of exercises.
Intervention Type
Procedure
Intervention Name(s)
Closed Kinetic Chain
Intervention Description
Patients assigned to this group will receive a 40-min multimodal supervised physical therapy treatment comprised of warm-up (10-min cycling/walking), three sets of 10 repetitions of 60% of one-repetition maximum (1RM) of seated leg press and partial squat exercises, neuromuscular control exercises, and ten-minute transcutaneous electrical nerve stimulation (TENS). Manual mobilization techniques may be applied as necessary according to the findings of the physical examination. Treating physical therapists will prescribe exercises based on a predetermined list of exercises.
Intervention Type
Procedure
Intervention Name(s)
Open Kinetic Chain
Intervention Description
Patients assigned to this group will receive a 40-min multimodal supervised physical therapy treatment comprised of warm-up (10-min cycling/walking), three sets of 10 repetitions of 60% of one-repetition maximum (1RM) of Quadriceps seated strengthening and Hamstring curl-up exercises, neuromuscular control exercises, and ten-minute transcutaneous electrical nerve stimulation (TENS). Manual mobilization techniques may be applied as necessary according to the findings of the physical examination. Treating physical therapists will prescribe exercises based on a predetermined list of exercises.
Primary Outcome Measure Information:
Title
Change in pain score using the Arabic version of the Western Ontario and McMaster Universities (WOMAC) index
Description
A 5-point Likert scale comprised of 24 questions across 3 subscales. Standardized answers are assigned a score from 0 (no symptoms) to 4 (extreme symptoms) with higher scores indicating worst pain, stiffness, and function.
Time Frame
Baseline, 2, and 6 months follow-up
Title
Change in function score using the Arabic version of the Western Ontario and McMaster Universities (WOMAC) index
Description
A 5-point Likert scale comprised of 24 questions across 3 subscales. Standardized answers are assigned a score from 0 (no symptoms) to 4 (extreme symptoms) with higher scores indicating worst pain, stiffness, and function.
Time Frame
Baseline, 2, and 6 months follow-up
Secondary Outcome Measure Information:
Title
Change in knee pain using the Arabic version of the Numeric Pain Rating Scale (ANPRS)
Description
A horizontal 11-point scale (0-10), with 0 indicating no pain and 10 indicating the worst pain ever.
Time Frame
Baseline, 2, and 6 months follow-up
Title
Change in isometric muscle strength
Description
Measured in Newtons for the Quadriceps and Hamstring muscles using a hand-held dynamometer (Commander Muscle testing, JTech, USA). The greater the recorded value the better the muscle strength.
Time Frame
Baseline, 2, and 6 months follow-up
Title
Change in knee joint range of motion (ROM)
Description
Active knee joint flexion/extension ROM measured in degrees using an electric goniometer (Biometrics Ltd, DLK900, UK). The greater the recorded value the greater the knee joint ROM.
Time Frame
Baseline, 2, and 6 months follow-up
Title
Change in knee joint proprioception
Description
Active repositioning error of a given passive position of the knee joint will be assessed using an electric goniometer (Biometrics Ltd, DLK900, UK). The lesser the recorded value the better the knee joint proprioception.
Time Frame
Baseline, 2, and 6 months follow-up
Title
Change in knee OA biomarkers
Description
Serum (10 ml blood) and urine samples will be collected from the participants and analyzed using the Enzyme-linked immunosorbent assay (ELISA) technique.
Time Frame
Baseline, 2, and 6 months follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥40 years of age;
having knee pain;
having at least three of the following additional symptoms: a-morning stiffness ≤ 30 minutes, b-crepitation, c-bone margin tenderness, d-bony enlargement or e-no palpable warmth;
willing to provide informed consent
Exclusion Criteria:
Knee joints showing Kellgren and Lawrence (K-L) grades 1 or 4;
rheumatoid arthritis;
serious pathological conditions (inflammatory arthritis and malignancy); total or partial arthroplasty of the affected knee joint, or on a waiting list for joint replacement surgery;
recent surgical procedure of the lower extremities in the previous 6 months;
uncontrolled hypertension and unstable cardiovascular problems that could subject the participant to increased risk with exercise and physical exertion;
physical incapability to safely perform exercises, walking or stationary cycling, as in debilitating visual defects, neurological problems, exaggerated low back pain, advanced osteoporosis, and inability to walk 10 meters without an assistive device;
use of prescribed analgesics, corticosteroid or analgesic injection intervention for knee pain within the previous 30 days;
lack of clear comprehension of study procedures or inability to comply with instructions;
stated inability to attend or complete the proposed course of intervention and follow-up schedule.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Farrag, PhD
Phone
+966 38440000
Ext
6941
Email
afarrag@psmchs.edu.sa
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Farrag, PhD
Organizational Affiliation
Prince Sultan Military College of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Fahd Military Medical Complex
City
Dammam
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Farrag
12. IPD Sharing Statement
Plan to Share IPD
No
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Different Modes of Isotonic Exercises for Knee Osteoarthritis
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